MalocclusionPhase 1NCT00155311
The Regulation of Osteoprotegerin by Mechanical Stimulation
A Phase 1 study testing orthodontic treatment in people with Malocclusion, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with two mandibular impaction third molars containing at least one mesially angular impaction with crown exposed to the oral cavity
Who cannot join
- pregnancy or diseases with abnormal bone metabolism
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dentistry, National Taiwan University Hospital
Taipei
About this study
To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
Read the detailed description
Long treatment time is a major factor causing high fee for orthodontic treatment. Patients would have dental caries or periodontitis resulted from improper oral hygiene care during this long treatment period. Therefore, how to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on tooth induces bone resorption on the compression side and bone deposition on the tension side, thus bone remodels and then tooth moves. Bone resorption is a complex process. Osteoblasts play an important role during initiation of bone resorption.
Changes OPG expression of osteoblasts under mechanical stimulation can play a role in bone remodeling. In order to test this hypothesis, the following specific aims will be achieved:
- To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
- To optimize the regulation by changing magnitude and frequency of pressure, and characterize the time table for these changes..
- Conditions
- Malocclusion
- Being tested
- orthodontic treatment
- Keywords
- orthodontic tooth movement, OPG, RANKL
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| days after treatment | Experimental | different days after orthodontic treament, samples will be taken. Receives: Procedure: orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPG staining
at 1, 3, 7 days after orthodontic force application on wisdom teeth, bone covering the tooth will be removed before taking the wisdom tooth out. The tissue section of the bone will be done with immunocytochemistry after de-calicification.
Measured: at most 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chung-Chen Yao, DDS, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155311
- Sponsor's protocol ID
- 9361700741
- Status last verified
- Mar 2013
- First submitted
- 8 Sep 2005
- Last updated
- 15 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulation of Osteoprotegerin by Mechanical Stimulation
- ClinicalTrials.gov ID
- NCT00155311
- Acronym / sponsor ID
- 9361700741
- Conditions
- Malocclusion
- Keywords
- orthodontic tooth movement, OPG, RANKL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
Detailed description
Long treatment time is a major factor causing high fee for orthodontic treatment. Patients would have dental caries or periodontitis resulted from improper oral hygiene care during this long treatment period. Therefore, how to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on tooth induces bone resorption on the compression side and bone deposition on the tension side, thus bone remodels and then tooth moves. Bone resorption is a complex process. Osteoblasts play an important role during initiation of bone resorption.
Changes OPG expression of osteoblasts under mechanical stimulation can play a role in bone remodeling. In order to test this hypothesis, the following specific aims will be achieved:
- To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
- To optimize the regulation by changing magnitude and frequency of pressure, and characterize the time table for these changes..
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| days after treatment | Experimental | Procedure: orthodontic treatmentdifferent days after orthodontic treament, samples will be taken. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with two mandibular impaction third molars containing at least one mesially angular impaction with crown exposed to the oral cavity
Key exclusion criteria (1 listed)
- pregnancy or diseases with abnormal bone metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthodontic treatment | Procedure or surgery | days after treatment |
Primary outcome
OPG staining
Time frame: at most 7 days
at 1, 3, 7 days after orthodontic force application on wisdom teeth, bone covering the tooth will be removed before taking the wisdom tooth out. The tissue section of the bone will be done with immunocytochemistry after de-calicification.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Chen Yao, DDS, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing orthodontic treatment in people with Malocclusion, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPG staining (time frame: at most 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.